What is NDMA, the substance found to have contaminated many forms of valsartan?
According to the United States Environmental Protection Agency (EPA), N-Nitrosodimethylamine, or NDMA, is a “contaminant” that “forms in both industrial and natural processes.” Although NDMA presently is not commercially produced in its pure form in the United States, it previously has been used in the production of such wide-ranging products as “liquid rocket fuel, antioxidants, additives for lubricants, and softeners for copolymers.”
Nowadays, except for research purposes, NDMA no longer is produced for its own sake, but instead is formed as a byproduct of chemical reactions used in various industrial processes. An EPA list of potential NDMA sources in the modern world implicates a variety of large global industries, including “amine manufacturing plants, tanneries, pesticide manufacturing plants, rubber and tire manufacturers, fish processing facilities, foundries, dye manufacturers, and surfactant industries.” NDMA can even result from certain water-purification techniques that use chloramines to disinfect wastewater.
Once introduced into the environment, NDMA is incredibly pervasive, with NDMA contamination having been identified in the air, water, and soil. In humans, exposure primarily takes place through the oral consumption of contaminated food and beverages. the EPA warns that certain everyday items may contain NDMA, increasing the risk of human exposure. While humans are exposed to some levels of NDMA naturally in our environment, NDMA should never be present in prescription medications such as valsartan. Furthermore, contaminated valsartan contained thousands of times more NDMA than would typically be found in any food or water. Below are a list of items that have been found to contain some level of NDMA.
What are the health risks associated with NDMA?
The US Department of Health and Human Services (DHHS) similarly has concluded that NDMA “is reasonably anticipated to be a human carcinogen” after having identified tumors in the livers, respiratory tracts, kidneys, and blood vessels of experimental animals exposed to NDMA.
The EPA further cautions that NDMA exposure can cause liver damage in humans and reports other symptoms of NDMA exposure as including “headache; fever; nausea; jaundice; vomiting; abdominal cramps; enlarged liver; reduced function of liver, kidneys and lungs; and dizziness.”
If you or a loved one fears you have taken NDMA-contaminated valsartan and have suffered from any of the side effects listed above, contact the experienced team of attorneys at TheLawFirm.com now Call 1-888-612-8313 for a free valsartan lawsuit consultation with a licensed attorney!
How Did Contaminated Valsartan Get on the Market?
Prior to valsartan going generic it was sold under the brand name Diovan. Diovan, or name-brand valsartan was never contaminated with cancer-causing agents. However, when valsartan went generic, there was a race to the bottom on who could make valsartan the cheapest. Pharmaceutical companies then began to buy their active pharmaceutical ingredient (API), a fancy phrase for the part of a pill that contains valsartan, from foreign countries, such as China and India. These pharmaceutical companies in China and India decided to change the chemical process utilized to make name-brand valsartan when making their generic valsartan. This change in the chemical process to make generic valsartan greatly decreased the cost to manufacture valsartan, so much so that other pharmaceutical companies were unable to compete with the cheap Chinese and Indian generic valsartan. However, the change in the chemical process to make cheap generic valsartan also resulted in the formation of some of the most dangerous carcinogens. As a result of other pharmaceutical companies not being able to compete against the cheap and contaminated foreign generic valsartan, eventually, most of the United States supply of valsartan was contaminated with cancer-causing agents. Our valsartan attorneys allege that the Chinese and Indian manufacturers of contaminated valsartan should have known that the chemical process they utilized would result in valsartan with cancer-causing contaminates. Furthermore, our valsartan lawyers have alleged that the Chinese pharmaceutical company actually knew that they were shipping valsartan contaminated with cancer-causing agents in it to the United States!
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